A Phase 2 clinical trial evaluating ONL-1204, a first-in-class FAS inhibitor, has shown promising results as an adjunctive treatment for rhegmatogenous retinal detachment (RRD). The study suggests that ONL-1204 may offer visual benefits for patients at higher risk of vision loss following surgical repair of RRD.
The trial, a real-world study that enrolled rapidly, investigated the efficacy of ONL-1204 in patients undergoing standard surgical repair for RRD. Durga Borkar, MD, presented the findings at the Retina Society meeting in Lisbon, Portugal.
Study Design and Results
Patients with RRD were randomized to receive either 50 micrograms or 200 micrograms of ONL-1204 via a single intravitreal injection, or a sham injection, as an adjunct to standard surgical repair. The treatment was administered at the baseline visit, with surgical repair scheduled between 12 hours and 10 days post-injection. Patients were then followed for six months.
While the primary endpoint of contrast sensitivity did not significantly differ between the groups, notable visual benefits were observed in a specific subgroup. "ONL-1204 ophthalmic solution delivered intravitreally did demonstrate visual benefit for those most at risk of vision loss," Dr. Borkar explained. This included patients with macula-off RRD of greater than 8 days duration, with the most pronounced effects seen in pseudophakic patients.
Mechanism of Action and Clinical Significance
ONL-1204 is designed to inhibit the FAS receptor, a key regulator of cell death and inflammation within the TNF receptor family. RRD, even with timely surgical intervention, can lead to significant vision loss. An adjuvant treatment like ONL-1204 could potentially improve visual outcomes for these patients.
Next Steps
The research team plans to conduct further subgroup analyses of the Phase 2 data and publish the results. They also intend to meet with the FDA to discuss the findings and inform the design of subsequent clinical trials. "The results of this study really help inform the design of subsequent clinical trials evaluating this and really show promise as an adjutant for RRD repair," Dr. Borkar noted.
